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The Advisory Committee on Immunization Practices (ACIP) of the CDC met on February 21 to 22 to provide guidance on vaccines. Read the key highlights:

​The Advisory Committee on Immunization Practices (ACIP) of the CDC met on February 21 -22 to provide guidance on vaccines. Below are the key highlights:

•Live Attenuated Influenza Vaccine (LAIV, FluMist®; MedImmune/AstraZeneca) was reinstated as an option to be used to protect against influenza for the 2018-2019 season. Fluarix® (GSK) has a new age indication at its 0.5mL dose down to 6 months of age.

•A new adjuvanted hepatitis B vaccine (HEPLISAV-B®, Dynavax) was recommended for adults age 18 and older. HEPLISAV-B® is administered as a 2-dose series separated by one month and performs with higher seroprotection rates than Engerix-B® with a similar safety profile.

•Hepatitis A vaccine was recommended to be used for post-exposure prophylaxis for all individuals age 12 months and older, and in conjunction with IG for persons >40 years at the provider’s discretion. Infants age 6-11 months at risk of hepatitis A due to international travel should be vaccinated. Then at age 12 months they should be vaccinated with the regular 2-dose series.

•Future: Evidence on the increasing rate of HPV positive oropharyngeal cancer was presented. Harmonization of the male and female HPV vaccine recommendation will be presented at a future meeting. Data concerning the direct and indirect effects of PCV13 (Prevnar; Pfizer) on IPD and CAP in adults >65 years was presented in expectations of a potential modification of its recommendation. The formation of a work group was requested to review evidence regarding vaccines to prevent health-care associated infections such as S. aureus, P. aeruginosa and C. difficile.

CURRENT RECOMMENDATIONS

Influenza Vaccine

The ACIP has voted to reinstate Live Attenuated Influenza Vaccine (LAIV, FluMist®) as an option for the 2018-2019 influenza season. ACIP had withdrawn its support of LAIV over the previous two influenza seasons due to data indicating poor efficacy of the vaccine against A/H1N1. AstraZeneca has chosen a new A/H1N1 strain to include in its Live Attenuated Influenza Vaccine (LAIV, FluMist®). The (A/Slovenia) strain has been shown to be more immunogenic with higher seroconversion and nasal IgA increase in children than the (A/Bolivia) strain that has been used in LAIV since the A/H1N1 pandemic season.

LAIV (FluMist®) is comparably as efficacious as inactivated influenza vaccine (IIV4) against Influenza Type B and A/H3N2. In an analysis by the CDC of multiple studies over past seasons since the pandemic, it was determined that the use of LAIV reduced the chance of children becoming infected with any influenza by 45% compared to unvaccinated children. Children who received the old formulation of LAIV were 2.52 times more likely to become infected with influenza A/H1N1 than children who received IIV. There is still no data concerning the effectiveness of the new LAIV formulation against A/H1N1.

ACIP chose not to preferentially recommend IIV, but to list LAIV as a viable option along with IIV and RIV.

While LAIV was approved to be added to the Vaccines for Children (VFC) program, the CDC reported that state health department VFC programs have already completed their vaccine orders for the 2018-2019 season and would be too late for the CDC to add a contract permitting health departments to purchase LAIV; AstraZeneca is indicating that may not be the case for all states. It is yet to be determined if the Utah VFC program will have any LAIV available for the 2018-2019 season.

Intermountain’s primary strategy will be to preferentially provide IIV4 in the 2018-2019 season, but to offer LAIV to those who will not receive an injectable IIV4 since vaccination with LAIV is demonstrably better than no vaccination.

Fluarix® (D-QIV; GSK) in a 0.5mL dose for infants was shown to be highly immunogenic, to have high effectiveness, and a good safety profile and was approved by the FDA down to age 6 months and is recommended by ACIP. Other vaccines approved for the 6 – 35 month age group include Flulaval® (Q-QIC; GSK) 0.5mL dose and Fluzone® (Sanofi) 0.25mL dose. While the volume per dose varies between these products, all products still follow the same schedule for the number of doses administered depending on age.

Interim Vaccine Effectiveness (VE) for the 2017-2018 season is reported as 36% for all types, 67% for

A(H1N1), 42% for B types, and 25% for A(H3N2). In this season where A(H3N2) predominated, that strain created the greatest number of hospitalizations for influenza since the 2014-2015 season and the highest rate of Influenza-like Illness (ILI) since the 2009 pandemic. The vaccine A(H3N2) strain was well matched to the circulating A(H3N2) virus, but all vaccines had low efficacy against this viral strain as is commonly seen with type A(H3N2) virus.

Hepatitis B Vaccine (HEPLISAV-B™)

Hepatitis B vaccine was recommended for children in 1991, and protection from current hepatitis B vaccines lasts greater than 30 years. Still, there are an estimated 850,000 to 2.2 million individuals living with hepatitis B virus (HBV) infection in the US. In the US, and 5,000-6,000 die each year due to hepatitis B complications. The increase in acute cases over the last couple of years is mainly due to a concomitant rise in injection-drug use.

Completion of the 3-dose vaccine series can be challenging in adults. The Vaccine Safety Datalink (VSD) reports that of those adults receiving the Hepatitis B vaccine series, 15.1-25.7% adults receive only 1 dose and 12.5-21.2 % only receive 2 doses of the 3 dose series.

ACIP voted to approve the use of a new adjuvanted recombinant hepatitis B vaccine (HEPLISAV-B®, Dynavax) in adults age 18 and older. HEPLISAV-B™ is administered as a 2-dose series separated by a minimum of 1 month between doses. HEPLISAV-B™ consists of a small synthetic oligonucleotide with immunostimulatory CpG motifs that enhance B and T cell responses to co-administered vaccine antigens.

The committee viewed evidence from a trial comparing HEPLISAV-B™ to Engerix-B®. HEPLISAV-B™ performs with higher seroprotection rates (90-100%) than Engerix-B® (70.5%-90.2%) and a similar safety profile. HEPLISAV-B™ causes 4.6% more local injection site reactions. More cardiovascular events were noted in the HEPLISAV-B™ arm of the study. While this was not statistically significant, this will be monitored in post-approval studies. HEPLISAV-B® induces high rates and earlier seroprotection in populations with reduced response to current vaccines such as diabetics and those with CKD. Adherence is anticipated to increase with a 2-dose schedule over a 3-dose schedule.

The 2-dose series only applies when all doses administered are HEPLISAV-B™. When any other product is used, a full 3 doses of hepatitis B vaccine must be administered, but HEPLISAV-B™ can be used as any of those 3 doses. Minimal intervals should be heeded (Exception: a series containing two doses of HEPLISAV-B™ administered at least 4 weeks apart is valid, even if the patient received a single earlier dose from another manufacturer). HEPLISAV-B™ may be used for a revaccination series due to insufficient titers following an initial hepatitis B vaccine series that consisted of doses of HEPLISAV-B® or doses from a different manufacturer. Post vaccination serologic testing and revaccination guidance remains unchanged.

Intermountain is still analyzing its portfolio of vaccine contracts and HEPLISAV-B cost-effectiveness to determine whether HEPLISAV-B will be used in the system.

Hepatitis A

Hepatitis A vaccine was recommended to be used for post-exposure prophylaxis for all individuals age 12 months and older, and in conjunction with immune globulin (IG) for persons >40 years at the provider’s discretion. Factors to consider in the decision to use IG in addition to vaccine include the patient’s age, immune status, and underlying conditions, exposure type, risk of transmission and availability of IG. This recommendation is primarily focused on use in outbreak settings where public health officials will act as consultants to providers in deciding who should be considered for IG.

ACIP also recommended that infants age 6-11 months at risk of hepatitis A due to international travel should be vaccinated, and then at age 12 months should be vaccinated with the regular 2-dose series. IG had previously been recommended for this age group, but many infants traveling outside of the US are also at risk for exposure to measles, and are recommended to receive MMR vaccine. IG and MMR should not be administered simultaneously; so, immunization with a hepatitis A vaccine is a better strategy for that age group.

Safety - Shingrix®

As vaccine administrators are new to the recommendations surrounding the provision of Shingrix®, the CDC is receiving numerous reports of administration errors. The CDC reminds providers that Shingrix® is to be refrigerated, not frozen. It is to be given IM, not subcutaneously. It needs to be reconstituted with the appropriate diluent. Also, providers need to make sure to tell patient to come back for second dose.

FUTURE RECOMMENDATIONS

Evidence was presented in the ACIP meeting to inform the committee concerning future vaccine recommendations.

PCV13 – Prevnar®

Data was presented about the effectiveness of PCV13 to prevent Invasive Pneumococcal Disease (IPD) and Pneumococcal pneumonia. The Work Group is continuing to inform the ACIP members in preparation for possible decisions either to no longer recommend PCV13 to the population age 65+, or to expand the recommendation of PCV13 to the adult population younger than 65 years.

Human Papilloma Virus

The HPV work group is discussing the extension of male HPV vaccine up to age 26 years to harmonize with the female recommendation. Data on the increasing incidence of HPV-positive oropharyngeal cancer was presented, particularly its predominance in males. The work group plans to present this for a vote in 2018.

Health Associated Infections

The National Center for Emerging Zoonotic and Infectious Diseases requested the creation of a Work Group in 2018 to evaluate vaccines to prevent Health Associated Infections such as post-surgical S. aureus, P. aeruginosa and C. difficile